A Phase I, Single Center, Open Label, Randomized, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of NP101 (Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex® in Healthy Volunteers

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Orlando,
Florida32809

Purpose:

The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently
approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and
to assess the bioavailability relative to the 6 mg subcutaneous injection.
The secondary objective is to evaluate the safety of NP101 in healthy volunteers.

Criteria:

Inclusion Criteria:
- Healthy men or women aged 18 to 65 years.
- Women of childbearing potential must be using a medically acceptable form of birth
control for the duration of the study, and must have a negative serum pregnancy test
at screening and a negative urine pregnancy test on Day -1 for all periods.
- Subjects must have body mass index (BMI) of 18 to 30 kg/m2 inclusive.
- Subjects must be able to communicate effectively with the study personnel.
- Subjects must have, in the investigator's opinion, no clinically significant disease
or abnormal laboratory values as determined by medical and psychiatric history,
physical examination, or laboratory evaluations conducted at the screening visit or
on clinic admission.
- Subjects must have a 12-lead ECG without any clinically significant abnormalities of
rate, rhythm, intervals or conduction, as determined by the investigator.
- Subjects must be nonsmokers, defined as having not used any tobacco products in the 6
months before screening.
- Subjects must have not consumed alcoholic beverages, poppy seeds, grapefruit, and/or
grapefruit juice within 72 hours prior to admission to the clinic for Period 1 and
for the duration of the study.
- Subjects must be adequately informed of the nature and risks of the study and give
written informed consent prior to screening.
- The subject must be likely to complete the entire study.
Exclusion Criteria:
- Female subjects who are pregnant or breast feeding or planning a pregnancy during the
study.
- A known hypersensitivity to sumatriptan or other triptan agents or the recipients of
any of the formulations.
- Subject currently has hypertension with blood pressure outside of normal range for
age group.
- Subject has hemiplegic or basilar migraine.
- Subject has severe hepatic impairment.
- Subject has any skin irritation or disease that might interfere with absorption of
study drug or skin irritation assessment, including eczema, psoriasis, melanoma, or
acne.
- Subject has a tattoo that might interfere with skin erythema examination.
- Subject has a positive test result for hepatitis B, or C or is known to be HIV
positive or have a medical history of AIDS.
- Subject who has been administered an injectable drug, except for local anesthetic or
birth control, within 30 days prior to the initial study drug administration.
- Subject who requires any medication on a regular basis.
- Subject with a history of malignancy within the past 5 years (except for squamous or
basal cell carcinoma of the skin that has been treated with no evidence of
recurrence).
- Subject with a hemoglobin (Hgb) level of less than 7.5 mmol/L.
- Subject has a history, symptoms, or signs of ischemic cardiac, cerebrovascular, or
peripheral vascular syndromes.
- Recent (within one year of screening) history of alcohol abuse, illicit drug use,
physical dependence to any opioid, or recent (within one year of screening) history
of drug abuse or addiction.
- Concurrent use of prescription (Rx) or over-the-counter (OTC) medications or natural
medicine (herbal) products.
- Subject is currently taking MAO-A inhibitors
- Receipt of an investigational drug or participation in any clinical study within 90
days prior to study entry.
- Donation of blood or blood products within 8 weeks prior to study entry.
- Positive urine drug screen, including ethanol, cocaine, THC, barbiturates,
amphetamines, benzodiazepines, and opiates.
- Subject who is considered by the investigator or NuPathe, for any reason, to be an
unsuitable candidate for receiving sumatriptan, or as being unsuitable for any other
reason as judged by the investigator.